Paradym RF CRT-D 9750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08031527012278), received between Jun 13, 2018 and Jul 13, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P060027); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2021Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  REPORTEDLY, THE PATIENT HAD DIZZINESS FOR A COUPLE OF WEEKS. UPON INTERROGATION OF THE CRT-D, NOISE OVERSENSING AND LOSS OF CAPTURE WERE OBSERVED ON THE RIGHT VENTRICULAR CHANNEL. PRELIMINARY ANALYSIS REVEALED THAT A VENTRICULAR LEAD ISSUE IS SUSPECTED.

  Patient problems: Dizziness

  MAUDE report 12163802 ↗
• MalfunctionJun 1, 2021Reset Problem; Reset Problem

  REPORTEDLY, UPON DEVICE INTERROGATION ON (B)(6) 2021, A WARNING STATING THAT A RESET OCCURRED ON (B)(6) 2021 AND RE-INITIALIZATION WAS PERFORMED WAS DISPLAYED. THE LAST BATTERY REFORMING WAS PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE BATTERY VOLTAGE WAS AT 2.88V. A CHARGE TIME OF 15S WAS MEASURED. THE DEVICE WAS SUCCESSFULLY REPROGRAMMED AND THE STATISTICS WERE RESET. PROPER DEVICE OPERATION WAS OBSERVED. THE PATIENT HAD UNDERGONE SEVERAL SURGERIES SINCE THE BEGINNING OF THE YEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913198 ↗
• InjuryDec 31, 2020Premature Discharge of Battery; Premature Elective Replacement Indicator; Premature Discharge of Battery; Premature Elective Replacement Indicator

  REPORTEDLY, THE SUBJECT DEVICE REACHED THE RECOMMENDED REPLACEMENT TIME (RRT) EARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11100333 ↗
• InjuryJun 13, 2018Device Operates Differently Than Expected; Inappropriate or Unexpected Reset; Device Operates Differently Than Expected; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE SUBJECT DEVICE PRESENTED A RESET WARNING MESSAGE DATED (B)(6) 2018 AND PARAMETERS HAD BEEN REPROGRAMMED TO VVI MODE AT 60 BPM WITH A VF ZONE AT 190 BPM. REPORTEDLY, FOLLOW-UP TESTING WAS PERFORMED WITH NO ABNORMALITIES OBSERVED AND THE DEVICE WAS RE-PROGRAMMED SUCCESSFULLY TO THE PRE-RESET PARAMETERS. A CHARGE TIME TEST DID NOT REVEAL ANY IRREGULARITY. THE PATIENT HAS RECENTLY COMPLAINED OF CHEST PAIN AND HAS COME TO THE EMERGENCY ROOM SEVERAL TIMES COMPLAINING OF A TINGLING IN THEIR CHEST.

  Patient problems: Chest Pain

  MAUDE report 7595229 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060027. One submission often covers many models, so check the product and lot details in each record.

• Z-3230-2017 · Jul 24, 2017 · Terminated
  Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single
• Z-3233-2017 · Jul 24, 2017 · Terminated
  Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single c
• Z-2579-2010 · Jun 7, 2010 · Terminated
  Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy